# K040736: Vaxcel Plus Chronic Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 18, 2004 after 57 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medcomp Split cath II: named in the summary without a submission number
- (no number) Bard Hickman catheter: named in the summary without a submission number

## Most influential descendants
- K071422: 15.5F Hemo-Stream Hemodialysis Catheter Set (2007), 5 descendants of its own
- K102043: Ultrastream Chronic Hemodialysis Catheter (2010), 4 descendants of its own
- K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own
- K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own
- K173667: 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm  Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm  Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (2018), 1 descendant of its own

## Recalls of this device
- Jul 22, 2005 · Not classified · Z-1500-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1499-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1502-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1501-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1503-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

## Indications for use
The VaxcelTM Plus Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis. Catheter lengths of 37 cm and 50 cm are indicated for femoral vein insertion.

Source page: https://510kreport.com/device/K040736
Methodology: https://510kreport.com/methodology